Clin Chem Lab Med. 2026 Jul 15. doi: 10.1515/cclm-2026-0671. Online ahead of print. ABSTRACT OBJECTIVES: Capillary blood sampling enables minimally invasive testing and decentralized workflows, but interchangeability with venous specimens may depend on collection site, device, and matrix. METHODS: We conducted a single-center, paired clinical study of 480 adults yielding 960 capillary specimens (fingertip lancet … Read more
Clin Chem Lab Med. 2026 Jul 14. doi: 10.1515/cclm-2026-0684. Online ahead of print. ABSTRACT OBJECTIVES: Peritonitis is a feared complication to peritoneal dialysis (PD), requiring empirical broad-spectrum antibiotics. A rapid method to predict culture positivity and bacterial Gram classification could enable earlier targeted therapy and reduce unnecessary antibiotic exposure. This study evaluated the diagnostic performance … Read more
Clin Chem Lab Med. 2026 Jul 14. doi: 10.1515/cclm-2026-0463. Online ahead of print. ABSTRACT OBJECTIVES: Schistocyte quantification is essential for diagnosing microangiopathic hemolytic anemia (MAHA) and thrombotic microangiopathies (TMA). Early exclusion is critical for guiding appropriate management. However, the reference standard remains time-consuming manual microscopy, highly operator-dependent. In this study, the CellaVision Advanced RBC Application … Read more
Clin Chem Lab Med. 2026 Jul 13. doi: 10.1515/cclm-2026-0647. Online ahead of print. ABSTRACT OBJECTIVES: Inductively coupled plasma-mass spectrometry (ICP-MS) is a gold standard for testing trace elements. Despite its wide adoption in clinical laboratories, sample preparation workflows are typically manual and prone to environmental contamination. The objective of this study was to develop an … Read more
Clin Chem Lab Med. 2026 Jul 10. doi: 10.1515/cclm-2026-0108. Online ahead of print. ABSTRACT OBJECTIVES: Quantitation of plasma vitamins A and E is essential for assessing nutritional status. Traditional methods typically involve liquid-liquid extraction followed by high-performance liquid chromatography with UV detection (HPLC-UV). In this study, we evaluated an automated sample extraction-method paired with liquid … Read more
Clin Chem Lab Med. 2026 Jul 10. doi: 10.1515/cclm-2026-0938. Online ahead of print. ABSTRACT OBJECTIVES: Approximately 30 % of laboratory tests are ordered inappropriately, substantially impacting patient care, costs, and carbon footprint of laboratories. Predefined laboratory test panels are a pragmatic and routinely used tool in laboratories, where tests are bundled for efficiency to diagnose … Read more
Clin Chem Lab Med. 2026 Jul 10. doi: 10.1515/cclm-2026-0643. Online ahead of print. ABSTRACT The 2015 Milan consensus proposed three models for analytical performance (APS) specifications for laboratory tests. Model 1 recommends defining analytical performance specifications based on impact on clinical outcomes. We undertook a targeted literature review to identify and evaluate studies using indirect … Read more
Clin Chem Lab Med. 2026 Jul 10. doi: 10.1515/cclm-2026-0977. Online ahead of print. ABSTRACT This collective opinion paper, based on presentations delivered during the two-day European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Strategic Conference 2026, “Laboratory Medicine for Society” (Prague, Czech Republic, 24-25 April 2026) offers a forward-looking overview of the Federation’s strategic … Read more
Clin Chem Lab Med. 2026 Jul 10. doi: 10.1515/cclm-2026-0408. Online ahead of print. ABSTRACT OBJECTIVES: Point-of-care (POC) International Normalised Ratio (INR) testing provides rapid anticoagulation monitoring. Still, it is susceptible to systematic bias, particularly at supratherapeutic levels, which can lead to inappropriate warfarin dose adjustments and increased thrombotic risk. This study evaluated bias trends between … Read more
Clin Chem Lab Med. 2026 Jul 10. doi: 10.1515/cclm-2025-0872. Online ahead of print. ABSTRACT OBJECTIVES: Calibration is a cornerstone of clinical chemistry test results and maintaining an in-house LDT requires periodic renewal of calibrators. Here we present the introduction of a new set of native human serum calibrators, using different curve fitting approaches for long-term … Read more
Clin Chem Lab Med. 2026 Jul 10. doi: 10.1515/cclm-2026-0489. Online ahead of print. ABSTRACT OBJECTIVES: In polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS) syndrome, when monoclonal plasma cell proliferation is absent, it is considered ‘non-secretory POEMS syndrome’. We aimed to study whether M-protein was detectable by mass spectrometry (MS) in previously non-secretory POEMS syndrome. … Read more
Clin Chem Lab Med. 2026 Jul 9. doi: 10.1515/cclm-2026-0444. Online ahead of print. ABSTRACT A widely accepted approach to setting Analytical Performance Specifications (APS) in laboratory medicine is the Milan models. The Milan Model 1b is an approach in which APS are developed based on patient classification or clinical decision-making, noting that these factors are … Read more
Clin Chem Lab Med. 2026 Jul 9. doi: 10.1515/cclm-2026-0626. Online ahead of print. ABSTRACT OBJECTIVES: Identification of acute kidney injury (AKI) in neonatology and paediatrics continues to present challenges to laboratories. Emerging biomarkers are being developed which may offer early detection but haven’t been adopted in current guidelines yet. The aim of this IFCC survey … Read more
Clin Chem Lab Med. 2026 Jul 9. doi: 10.1515/cclm-2025-1488. Online ahead of print. ABSTRACT OBJECTIVES: Invasive prenatal diagnosis is recommended for high-risk pregnancies, but many decline due to potential complications. To date, no non-invasive prenatal testing (NIPT) simultaneously detects monogenic diseases, balanced chromosomal rearrangements (BCRs), and aneuploidies. We developed a comprehensive NIPT to detect monogenic … Read more
Clin Chem Lab Med. 2026 Jul 7. doi: 10.1515/cclm-2026-0957. Online ahead of print. ABSTRACT OBJECTIVES: Red blood cell (RBC) morphology in peripheral blood smears (PBS) remains essential for the differential diagnosis of anemia and other hematologic disorders. As yet unclassified poikilocytes, fish-shaped RBCs and pincer (mushroom-shaped) cells are rarely observed but have been described as … Read more
Clin Chem Lab Med. 2026 Jul 6. doi: 10.1515/cclm-2026-0789. Online ahead of print. ABSTRACT Clinical laboratory medicine faces converging structural pressures: workforce shortages, growing data complexity, and rapid advances in artificial intelligence (AI). Some prominent developers, including Demis Hassabis of Google DeepMind, have projected the arrival of artificial general intelligence (AGI) around 2030; such timelines … Read more
Clin Chem Lab Med. 2026 Jul 6. doi: 10.1515/cclm-2026-0743. Online ahead of print. ABSTRACT OBJECTIVES: Unified Code for Units of Measure (UCUM) encodes syntax without prescribing which unit should be used. The Nomenclature for Properties and Units (NPU) terminology, developed by IFCC and IUPAC, specifies both the kind-of-quantity (e.g., mass concentration or substance concentration) and … Read more
Clin Chem Lab Med. 2026 Jul 6. doi: 10.1515/cclm-2026-0661. Online ahead of print. ABSTRACT OBJECTIVES: The objective of this study is to evaluate the ethical dimensions of reflex and reflective testing (RRT) within the framework of value-based laboratory medicine and in alignment with ISO 15189:2022. The study aims to highlight the challenges in guiding and … Read more
Clin Chem Lab Med. 2026 Jul 2. doi: 10.1515/cclm-2026-0123. Online ahead of print. ABSTRACT Tuberculosis (TB), caused by Mycobacterium tuberculosis (Mtb), remains a global public health challenge. Rapid and accurate diagnostic methods are critical for effective TB control. In recent years, serological diagnosis has attracted growing attention with the continuous identification of novel biomarkers, owing … Read more
Clin Chem Lab Med. 2026 Jul 2. doi: 10.1515/cclm-2026-0173. Online ahead of print. ABSTRACT OBJECTIVES: Reliable biomarkers may allow early risk stratification for mortality in older adults. Post-translational modification-derived products (PTMDPs), such as homocitrulline, and the tissue accumulation of advanced glycation end products (AGEs), measured by skin autofluorescence, have been suggested as potential biomarkers of … Read more
Clin Chem Lab Med. 2026 Jul 1. doi: 10.1515/cclm-2026-0785. Online ahead of print. ABSTRACT OBJECTIVES: To evaluate how alternative age-partitioning strategies affect result classification using discrete pediatric ferritin reference intervals (RIs). METHODS: In a prospective cohort of 3,322 apparently healthy individuals aged birth to <19 years, serum ferritin was measured on the Cobas Pro platform. … Read more
Clin Chem Lab Med. 2026 Jul 1. doi: 10.1515/cclm-2026-0504. Online ahead of print. ABSTRACT OBJECTIVES: This study aimed to present the results of translating the LOINC standard into Polish, summarize key methodological lessons, and outline the current stage of LOINC implementation in Poland. METHODS: Three editions of the LOINC dictionary translation process were conducted using … Read more
Clin Chem Lab Med. 2026 Jul 1. doi: 10.1515/cclm-2026-0934. Online ahead of print. ABSTRACT Harmonization initiatives in laboratory medicine have a long history. Nevertheless, despite substantial efforts by international federations, scientific societies, and expert working groups, their implementation and widespread adoption remain incomplete, with many initiatives still at a relatively early stage of development. More … Read more
Clin Chem Lab Med. 2026 Jun 30. doi: 10.1515/cclm-2026-0034. Online ahead of print. ABSTRACT OBJECTIVES: Albuminuria is a key biomarker of kidney damage, yet preanalytical challenges with conventional liquid urine testing, limiting its utility for decentralized and large-scale screening. This study evaluated the analytical performance of a novel dried urine spot (DUS) device, for measuring … Read more
Clin Chem Lab Med. 2026 Jun 26. doi: 10.1515/cclm-2026-0346. Online ahead of print. ABSTRACT OBJECTIVES: Carbohydrate-deficient transferrin (CDT) is a specific biomarker for chronic excessive alcohol consumption. The IFCC Working Group on CDT Standardization recommends 2-sialo-transferrin (2-sialo-Tf) as the sole measurand, with a decision threshold of 2.0 % CDTIFCC using HPLC. This study evaluates the … Read more
Clin Chem Lab Med. 2026 Jun 26. doi: 10.1515/cclm-2026-0464. Online ahead of print. ABSTRACT OBJECTIVES: Accurate estimation of glomerular filtration rate (eGFR) is necessary for early detection and staging of chronic kidney disease (CKD), risk stratification, and guiding therapies that prevent complications and progression to advanced CKD. This study aimed to evaluate the performance of … Read more
Clin Chem Lab Med. 2026 Jun 26. doi: 10.1515/cclm-2026-0579. Online ahead of print. ABSTRACT OBJECTIVES: The high variability in screening and confirmatory cut-off values for primary aldosteronism (PA) largely reflects the insufficient standardization of current analytical methods. Competitive and sandwich immunoassays show variable correlation with the reference liquid chromatography-tandem mass spectrometry (LC-MS/MS) technique. This prospective … Read more
Clin Chem Lab Med. 2026 Jun 25. doi: 10.1515/cclm-2026-0757. Online ahead of print. ABSTRACT OBJECTIVES: Advanced medullary thyroid carcinoma (MTC) is commonly monitored using calcitonin (CT) and carcinoembryonic antigen (CEA) kinetics. Pro-gastrin-releasing peptide (ProGRP) and carbohydrate antigen 19-9 (CA 19.9) have emerged as potential complementary markers, but their longitudinal prognostic value remains unclear. METHODS: This … Read more
Clin Chem Lab Med. 2026 Jun 24. doi: 10.1515/cclm-2026-0259. Online ahead of print. ABSTRACT BACKGROUND: External quality assurance (EQA) programs must assess whether the analytical performance of commonly used in vitro diagnostic (IVD) devices is fit for their intended clinical use. We developed a method for this assessment based on reclassification of results at clinical … Read more
Clin Chem Lab Med. 2026 Jun 24. doi: 10.1515/cclm-2026-0658. Online ahead of print. ABSTRACT BACKGROUND: Prompt diagnosis and treatment of vitamin B12 deficiency prevents haematological, neurological, psychological and psychiatric disturbances. During November 2024, reference interval data used for the clinical interpretation of total B12 assays was collated from participants of the UK NEQAS for Haematinic … Read more
Clin Chem Lab Med. 2026 May 20. doi: 10.1515/cclm-2026-0553. Online ahead of print. ABSTRACT OBJECTIVES: Hereditary transthyretin amyloidosis (ATTRv) is a rare autosomal dominant disorder caused by pathogenic variants in the TTR gene, with marked clinical heterogeneity and frequent underdiagnosis. Genetic confirmation is essential for patient management but is traditionally based on Sanger sequencing or … Read more
Clin Chem Lab Med. 2026 May 19. doi: 10.1515/cclm-2026-0382. Online ahead of print. ABSTRACT OBJECTIVES: The 20- and 22-kDa isoforms of growth hormone 1 (GH1) play potentially distinct physiological and pathological roles, but their structural similarity makes quantification challenging. Conventional immunoassays lack sufficient specificity, highlighting the need for more precise analytical methods. METHODS: We developed … Read more
Clin Chem Lab Med. 2026 May 19. doi: 10.1515/cclm-2026-0276. Online ahead of print. ABSTRACT OBJECTIVES: A major objective of the IFCC Committee for Education in the Use of Biomarkers in Diabetes is to monitor the success of global standardization of HbA1c through benchmark evaluation of the performance by country and manufacturer. METHODS: From 2016 to … Read more
Clin Chem Lab Med. 2026 May 15. doi: 10.1515/cclm-2026-0179. Online ahead of print. ABSTRACT OBJECTIVES: Myositis specific antibodies (MSA) are important in the diagnosis of idiopathic inflammatory myopathies (IIM). In addition, several studies have shown clear utility to stratify IIM patients into more homogeneous subsets based on MSA signatures. However, methods for MSA detection show … Read more
Clin Chem Lab Med. 2026 May 15. doi: 10.1515/cclm-2026-0388. Online ahead of print. ABSTRACT OBJECTIVES: This study aimed to calculate the measurement uncertainty (MU) of HbA1c and glucose according to ISO/TS 20914:2019 guideline and to evaluate using indirect outcome-based analytical performance specifications (APS). METHODS: MU was estimated using internal quality control data collected between October … Read more
Clin Chem Lab Med. 2026 May 14. doi: 10.1515/cclm-2026-0320. Online ahead of print. ABSTRACT OBJECTIVES: Therapeutic drug monitoring (TDM) of tacrolimus is essential due to its high inter- and intra-patient variability and narrow therapeutic window. Conventional venous blood sampling may limit sampling frequency and patient convenience. Capillary dried blood spot (DBS) sampling represents a patient-centric … Read more
Clin Chem Lab Med. 2026 May 14. doi: 10.1515/cclm-2026-0419. Online ahead of print. ABSTRACT OBJECTIVES: Traditionally, neonates were screened for classical galactosaemia in 4 of the 5 jurisdictions in Australia creating inequitable access to early intervention. A push to nationally harmonise newborn bloodspot screening enabled the state of Victoria to proceed with implementation of screening … Read more
Clin Chem Lab Med. 2026 May 13. doi: 10.1515/cclm-2026-0590. Online ahead of print. ABSTRACT Harmonization in laboratory medicine is increasingly recognized as a fundamental requirement to ensure interchangeable laboratory information, avoid confusion among users, and ultimately improve patient safety. However, current evidence continues to highlight substantial gaps in harmonization across several dimensions of the total … Read more
Clin Chem Lab Med. 2026 May 11. doi: 10.1515/cclm-2025-1727. Online ahead of print. ABSTRACT OBJECTIVES: Pathological conditions may result in clinical chemical values exceeding the linearity range of laboratory methods. In clinical practice, not all tests require exact numerical values for patient management, as useful information can still be provided when results are reported to … Read more
Clin Chem Lab Med. 2026 May 11. doi: 10.1515/cclm-2026-0377. Online ahead of print. ABSTRACT A widely accepted approach to setting Analytical Performance Specifications (APS) in laboratory medicine is the Milan models. Milan model 1b is an approach where APS are developed based on patient classification, or clinical decision-making, noting that these factors link to the … Read more
Clin Chem Lab Med. 2026 May 11. doi: 10.1515/cclm-2026-0153. Online ahead of print. ABSTRACT OBJECTIVES: Few studies have systematically evaluated the factors contributing to laboratory errors in the analytical phase. This study analyzed five years of retest data to determine the frequency and characteristics of analytical errors across routine blood chemistry parameters, identify analytes most … Read more
Clin Chem Lab Med. 2026 May 5. doi: 10.1515/cclm-2026-0395. Online ahead of print. ABSTRACT OBJECTIVES: Plasma phosphorylated tau at threonine 217 (p-tau217) has emerged as a highly accurate blood-based biomarker of Alzheimer’s disease (AD) pathology. As disease-modifying anti-amyloid therapies enter clinical practice, scalable biomarkers with robust and clinically interpretable decision thresholds are required. However, evidence … Read more
Clin Chem Lab Med. 2026 May 7. doi: 10.1515/cclm-2025-1137. Online ahead of print. ABSTRACT OBJECTIVES: This study developed a pseudoviral human rhinovirus (HRV) reference material using pseudovirus technology and integrating RT-dPCR with HPLC-IDMS to achieve accurate HRV RNA quantification, aiming to standardize HRV detection across labs and platforms. METHODS: We developed an RT-digital PCR (RT-dPCR) … Read more
Clin Chem Lab Med. 2026 May 7. doi: 10.1515/cclm-2026-0580. Online ahead of print. ABSTRACT Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) was introduced to enhance patient safety and ensure the availability of safe and effective diagnostics across the European Union. However, its implementation has led to substantial unintended consequences, including certification bottlenecks, … Read more
Clin Chem Lab Med. 2026 May 6. doi: 10.1515/cclm-2026-0289. Online ahead of print. ABSTRACT OBJECTIVES: To evaluate the real-world impact of Point-of-Care Testing on care timeliness and patient flow in the emergency department. METHODS: A before-and-after, matched-cohort study was conducted involving 25,291 patients with Emergency Severity Index levels 3-4. A POCT group (n=8,746) was compared … Read more
Clin Chem Lab Med. 2026 May 6. doi: 10.1515/cclm-2026-0146. Online ahead of print. ABSTRACT OBJECTIVES: Dihydropyrimidine dehydrogenase (DPD) phenotyping through uracil and dihydrouracil determination is a well-established approach to identify (partial) DPD deficiencies prior to fluoropyrimidine chemotherapy. However, preanalytical stability has challenged this test for years. This study therefore investigated whether dried blood spots (DBS) … Read more
Clin Chem Lab Med. 2026 May 6. doi: 10.1515/cclm-2026-0577. Online ahead of print. ABSTRACT This article aims to define a minimum panel of essential laboratory tests to be used in emergency and disaster settings through expert consensus. A structured survey was distributed to the 24 members of the European Federation of Clinical Chemistry and Laboratory … Read more
Clin Chem Lab Med. 2026 Apr 29. doi: 10.1515/cclm-2025-1624. Online ahead of print. ABSTRACT OBJECTIVES: There has been a lot of interest in the field of laboratory medicine regarding the use of machine learning (ML)-based prediction models. The longitudinal ML-based Serum Tumor marker-based Outcome Prediction (STOP) model was previously developed to identify non-small cell lung … Read more
Clin Chem Lab Med. 2026 Apr 29. doi: 10.1515/cclm-2025-1356. Online ahead of print. ABSTRACT OBJECTIVES: Hypercalcemia has been associated with various non-specific minor neuropsychological symptoms but mainly in patient cohorts. Whether hypercalcemia is the cause or an innocent bystander in relation to these symptoms remains unclear. METHODS: We included 5,917 individuals from the Copenhagen City … Read more
Clin Chem Lab Med. 2026 Apr 29. doi: 10.1515/cclm-2026-0370. Online ahead of print. ABSTRACT OBJECTIVES: Plasma p-tau217 is a leading blood-based biomarker for Alzheimer’s disease (AD), offering high diagnostic accuracy and potential utility for treatment eligibility and monitoring. However, real-world data on concordance between cerebrospinal fluid (CSF) Aβ42/40 and plasma p-tau217 in routine clinical laboratory … Read more
Clin Chem Lab Med. 2026 Apr 20. doi: 10.1515/cclm-2026-0435. Online ahead of print. ABSTRACT OBJECTIVES: Large language models (LLMs) show promise for interpreting laboratory reports, yet real-world validation remains limited. This study evaluated five advanced LLMs in interpreting urinalysis reports for kidney diseases using real-world clinical data, providing empirical evidence for the utility of LLM-assisted … Read more
Clin Chem Lab Med. 2026 Apr 22. doi: 10.1515/cclm-2026-0080. Online ahead of print. ABSTRACT OBJECTIVES: To determine the prevalence of erythroid dysplasia and ring sideroblasts (RS) after peripheral blood stem cell transplantation (PBSCT), stratified by transplant type, and to assess the association with SF3B1 mutations and event-free survival (EFS). METHODS: In a retrospective single-center study, … Read more
Clin Chem Lab Med. 2026 Apr 21. doi: 10.1515/cclm-2026-0277. Online ahead of print. ABSTRACT INTRODUCTION: Brain-derived neurotrophic factor (BDNF) is a neurotrophin expressed in the central nervous system, where it supports synaptic plasticity, neuronal survival, and dendritic remodeling. Reduced circulating BDNF levels have been reported in several neurological and psychiatric disorders, increasing evidence links BDNF … Read more
Clin Chem Lab Med. 2026 Apr 20. doi: 10.1515/cclm-2025-1709. Online ahead of print. ABSTRACT OBJECTIVES: To evaluate whether antinuclear antibody (ANA) titre or HEp-2 fluorescence patterns are associated with antiphospholipid antibody (aPL) serological intensity, and to examine component-specific complement abnormalities – particularly low C4 – as laboratory correlates compatible with classical-pathway involvement. METHODS: This retrospective … Read more
Clin Chem Lab Med. 2026 Apr 13. doi: 10.1515/cclm-2026-0079. Online ahead of print. ABSTRACT OBJECTIVES: The basophil activation test (BAT) is increasingly used for diagnosing IgE-mediated food allergies, yet its performance in cow’s milk allergy (CMA) remain insufficiently characterized in real-world pediatric practice. This study evaluates the diagnostic accuracy of BAT for CMA and identifies … Read more
Clin Chem Lab Med. 2026 Apr 15. doi: 10.1515/cclm-2025-1673. Online ahead of print. ABSTRACT Adverse event in the perinatal period constitutes today the wider bulk of investigation. Perinatal asphyxia (PA) and prematurity are the common causes of injury of high risk pregnancies (HR) and can lead to perinatal death or cognitive and neuro-motor impairment in … Read more
Clin Chem Lab Med. 2026 Apr 16. doi: 10.1515/cclm-2025-1464. Online ahead of print. ABSTRACT OBJECTIVES: Low mitochondrial DNA copy number (mtCN) in leukocytes is a predictor of all-cause mortality, independent of age and sex. For malignant diseases, results about the prognostic value of leukocyte mtCN have been conflicting. Aim of the present study was to … Read more
Clin Chem Lab Med. 2026 Apr 15. doi: 10.1515/cclm-2026-0262. Online ahead of print. ABSTRACT OBJECTIVES: To establish discrete and continuous age-specific reference intervals for serum alpha-fetoprotein in children and to evaluate whether continuous modeling improves interpretation during early infancy, when concentrations decline rapidly. METHODS: In this prospective, cross-sectional study, serum alpha-fetoprotein was measured in 3,680 … Read more
Clin Chem Lab Med. 2026 Apr 15. doi: 10.1515/cclm-2026-0144. Online ahead of print. ABSTRACT OBJECTIVES: Testosterone is increasingly being measured in saliva due to the ease of collection, which puts a lower burden on patients and facilitates measurement in clinical and behavioral studies. Although the robustness of measuring testosterone in saliva using immunoassays has been … Read more
Clin Chem Lab Med. 2026 Apr 15. doi: 10.1515/cclm-2026-0155. Online ahead of print. ABSTRACT OBJECTIVES: The CA 19-9 tumor marker measures the sialylated Lewis a blood group antigen (sLe(a)) expressed on circulating proteins. CA 19-9 is primarily used to monitor pancreatic and gastrointestinal cancers. Studies have demonstrated the lack of comparability of CA 19-9 assays. … Read more
Clin Chem Lab Med. 2026 Apr 13. doi: 10.1515/cclm-2026-0236. Online ahead of print. ABSTRACT OBJECTIVES: Multitarget stool tests are approved for colorectal cancer (CRC) screening. Here we developed a multitarget stool test based on the fecal immunochemical test (FIT) and two (NDRG4 and SDC2) DNA methylation markers with a simple calling algorithm. METHODS: FIT, quantitative … Read more
Clin Chem Lab Med. 2026 Apr 13. doi: 10.1515/cclm-2026-0093. Online ahead of print. ABSTRACT OBJECTIVES: To evaluate the analytical performance and clinical workflow efficiency of the Flash10 molecular point-of-care testing (POCT) system for the detection of influenza A (FluA) and influenza B (FluB) viruses. METHODS: Throat swab specimens from 178 individuals presenting with influenza-like symptoms … Read more
Clin Chem Lab Med. 2026 Apr 13. doi: 10.1515/cclm-2026-0043. Online ahead of print. ABSTRACT OBJECTIVES: Several macro-hormones have been reported to date. Among them, macroprolactinemia is a common cause of hyperprolactinemia. Growth hormone (GH) and prolactin (PRL) are anterior pituitary hormones related by structure and function. The aim of this study was to clarify the … Read more
Clin Chem Lab Med. 2026 Apr 3. doi: 10.1515/cclm-2026-0109. Online ahead of print. ABSTRACT In precision medicine protein phenotypes are foreseen that combined with pattern recognition tools exhibit great potential in guaranteeing safe and accurate test results for patient management and intervention. For discovery purposes novel high-throughput technologies have emerged and this has led to … Read more
Clin Chem Lab Med. 2026 Apr 2. doi: 10.1515/cclm-2025-1694. Online ahead of print. ABSTRACT OBJECTIVES: This study aimed to compare the analytical and clinical performance of plasma glial fibrillary acidic protein (GFAP) across three immunoassay platforms. METHODS: Plasma GFAP was measured on three immunoassay platforms (Simoa HD-X, Maccura i1000, MS-Fast Pro 160) in 302 participants … Read more
Clin Chem Lab Med. 2026 Mar 20. doi: 10.1515/cclm-2026-0112. Online ahead of print. ABSTRACT OBJECTIVES: Indirect clinical outcome-based analytical performance specifications (APS) may offer a feasible alternative to direct studies but raise questions regarding data requirements and transferability. This study aimed to determine the minimum sample size for simulation-driven APS and to investigate the impact … Read more
Clin Chem Lab Med. 2026 Mar 20. doi: 10.1515/cclm-2026-0049. Online ahead of print. ABSTRACT OBJECTIVES: Patient-based real-time quality control (PBRTQC) represents a useful complement to traditional internal quality control methods, particularly in the continuous monitoring of routine analyses. Sodium, potassium, chloride, calcium, phosphorus, and magnesium are critical for patient safety. This study aimed to evaluate … Read more
